AUTION EYE AI-4510 Urine Particle Analysis System is an AI-enabled medical device from Arkray Inc., listed by FDA (510(k), K232416) with a decision date of 2024-05-03. Review panel: Hematology.
| FDA submission number | K232416 |
|---|---|
| Pathway | 510(k) |
| Company | Arkray Inc. |
| Review panel (specialty) | Hematology |
| FDA decision date | 2024-05-03 |
| Decision | Substantially Equivalent |
| Product code | LKM |
| Classification | Counter, Urine Particle |
| Device class | 2 |
| Regulation number | 864.5200 |
| Review time (calendar days) | 266 |
| Applicant country | JP |
Official FDA database record · FDA AI-enabled device list
All Hematology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.